A Study of Simmitinib Plus Irinotecan in Advanced Esophageal Squamous Cell Carcinoma
- Sponsor
- Shanghai Runshi Pharmaceutical Technology Co., Ltd
- Study ID
- NCT06512428
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Advanced Esophageal Squamous Cell Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- simmitinib plus irinotecan liposome — DRUGsimmitinib plus irinotecan liposome 70 mg/m\^2 every 2 weeks
- irinotecan liposome — DRUGirinotecan liposome 70 mg/m\^2 every 2 weeks
- irinotecan — DRUGirinotecan 180mg/m\^2 every 2 weeks
Study Details
To evaluate the safety and efficacy of simmitinib plus irinotecan liposome in the treatment of advanced esophageal squamous cell carcinoma, and to evaluate the PK of the drug and the correlation between biomarkers and clinical efficacy of simmitinib plus irinotecan liposome.
Key Dates
- Start date
- Mar 15, 2024
- Status verified
- Jul 2024
- Primary completion
- Jan 30, 2026
- Completion
- Jan 30, 2026
Study Design
- Enrollment
- 138 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: simmitinib plus irinotecan liposome
- Experimental: irinotecan liposome
- Experimental: irinotecan
Primary Outcome Measure
Dose Escalation Phase: DLT [ Time Frame: From Cycle 1 Day 1 to Cycle 1 Day 28 (each cycle is 28 days) ]
Central Contacts
- Clinical Trials Information Group officer86-0311-69085587
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